British Report Laments Lack of Exposure Data on Carbon NanoTubes

The UK Department for Environment, Food and Rural Affairs (DEFRA) has issued a report arguing that there is an almost total lack of exposure data for carbon nanotubes (CNT) present in consumer products. The report "A Lifecycle Assessment Study of the Route and Extent of Human Exposure via Inhalation for Commercially Available Products and Applications Containing Carbon Nanotubes," was conducted by the Safety of nanomaterial Interdisciplinary Research Centre (SnIRC), with participation of other Academic and Industrial Experts.

As part of the study, "a review of all available CNT-containing products was carried out, and a representative subset of the products was identified for exposure analysis." The selected CNT-containing products were lithium-ion batteries, epoxy adhesive resins, and textiles. The study "assessed the suitability of current lifecycle assessment (LCA) protocols for assessing inhalation exposure from CNT and other nano-products."

The findings of the study indicate that:

* LCA is not a tool for exposure assessment. On the contrary, exposure assessments can provide information to LCA that is relevant for impact assessment of CNT releases. LCA is, however, useful in identifying the stages in the lifecycle during which exposure may be relevant.

* There is an almost complete lack of data to enable both a full-scale LCA, or a quantitative exposure assessment. Due to unavailability of the required data, a simplified LCA approach was adopted in this study, focusing on the potential inhalation exposure during the lifecycle of the selected CNT-containing products. Also, the exposure assessment was limited to qualitative analysis because of the lack
of data necessary for a quantitative assessment.

Furthermore, "both LCA and exposure analysis have shown that the material synthesis stage is prone to giving rise to inhalation exposure to CNTs. However, the few studies carried out so far have generally shown that nanoparticle emissions during synthesis can be effectively controlled through appropriate engineering measures. Significant inhalation exposure to CNT material at this stage should be preventable provided such processes are carried out under appropriate emission control and waste management procedures."

Therefore, the study concludes that "the main emphasis from the exposure point of view...needs to be on other stages/processes in the lifecycle of products, where any sophisticated emission control measures are not likely to exist." They specifically suggest as examples "postproduction handling, transportation, accidental release, and use and disposal of the relevant materials and products."

More on how the November elections may impact the TSCA Chemical Reform bills being debated

Yesterday I wrote a commentary piece about how the likely change in numbers of Republicans and Democrats could affect the ongoing discussions to revise TSCA. A commenter raised some good points so I thought today I would expand on my responses.

To begin with the commenter opined that my "political analysis in this case is simplistic and overly tied to conventional wisdom." He (or she, the comment was Anonymous) noted that "the industry position on TSCA reform is not at all monolithic. There are divisions within the ranks and conflicting needs from within the business community. Some industry industry interests want more than has been proposed. Others want the burden shifted to other sectors."

To which I wholeheartedly agree. In my reply I noted that "the industry position is not at all monolithic, nor for that matter is the NGO position or the positions of the individual companies (or of the American people, should they even have an opinion)." I also pointed out that "clearly the end user, small enterprise, and specialty manufacturers and formulators have different desires, and concerns, than the larger manufacturers. This is especially true in comparison to the multinational companies who may find that their significant resources and prior data generation for HPV and REACH gives them a distinct competitive advantage."

The "environmental/health friendly tone" you ascribe to the current bills belies the fact that there are many in that camp that find portions of the proposals to be unworkable and incomplete on practical grounds.

Again, I agree. Not surprisingly "there are portions of the proposals that are more than acceptable, and patently unacceptable, to both sides (and all the other sides)." Furthermore, I also agreed "that the situation is much more intricate, intertwined, and complicated than what can be presented in the very limited space I had available." I believe I've discussed many of these differences of opinion and the desired options of various stakeholders in my previous writings in this post. Yesterday's posting was one of my occasional commentaries in which I speculated "on the influences of a likely change in political power after November."

Then there's the American people, who overwhelmingly want safer products. Then there's the state chemical policy experiment where every new law has been voted in with overwhelming bipartisan support.

I actually didn't address this directly in my reply but here again the commenter makes an excellent observation. Clearly "the American people" want safe products. However, defining what is "safe" and how to demonstrate it is obviously more difficult than simply saying you want safe products. Many of the "American people," for example, also don't want too much government interference that could stifle innovation. Where is that line?

The political landscape for safer chemicals legislation is complicated and will defy conventional partisan analysis in the end.

I suppose my piece yesterday did seem to suggest "conventional partisan analysis," but if that is the case it certainly doesn't reflect my understanding of the process. On the other hand, wisdom becomes conventional for a reason...there is usually good support for it, at least on the general level.

I agree we'll see substantive TSCA reform, but I find it senseless to speculate around a duality of who it will be friendlier to when that reality doesn't really exist.

I disagree that such speculation is senseless. I noted that "to ignore the differences of position, even if they are generalities, is to ignore the realities of the debate." While I agreed earlier that the "conventional wisdom" is oversimplified (rather than merely "simplistic"), the fact is that the two parties have very different views on the level of government regulation that is appropriate. I think Representative Barton and the Republican Study Committee made that point quite clear this past week.

The fact is that most in industry feel the bills go too far in modernizing the law. And most of the advocacy NGOs would feel the bills do not go far enough in many respects. As the old adage says, "the devil is in the details." And I think most would agree that the preferred details lean one direction for the Republicans and the other direction for the Democrats. And while certainly within the caucuses there are shades of opinion, in the current partisan environment those shades are less and less gray and more and more black and white. I think this will have an influence on the nature of the final bills when they get reintroduced next year. Others may disagree.

Will the November Elections "Reform" TSCA Chemical Reform?

As anyone reading my posts on this site knows already, the US Congress has introduced bills in the House and Senate to reform/modernize TSCA, the 34 year old Toxic Substances Control Act. But those following the process also know that this year is a mid-term election year and that the minority party - the Republicans - are expected to make substantial gains in the number of seats they hold. Some believe that the Republican party will gain the majority in either the House or Senate, or both.

So what does this mean for TSCA reform?

It could mean a lot. The Democratic majority in key committees is led by very environmentally minded leadership from California - Barbara Boxer for the Senate EPW committee and Henry Waxman for the House Energy and Commerce Committee. Frank Lautenberg from New Jersey has also taken the lead in the Senate as chairman of the relevant subcommittee in Boxer's EPW committee. A Republican takeover would put significantly less environmentally and health-aware chairs in place. Even significant gains in seats would shift the balance of power more into the Republican view, which tends to put more emphasis on industry than would the Democratic view.

So would Republican gains kill TSCA reform? No. At least, probably not. Industry is generally in agreement that modernization of TSCA is necessary, primarily because industry would rather deal with one federal-level law than a hodgepodge of 50 state laws (plus a few regional rules tossed in to further complicate compliance).

So while some sort of TSCA reform in 2011 seems inevitable, most would agree that it will be more industry-friendly than the current bills being offered.

Another major concern is funding of EPA. No matter what the final law looks like, and despite the desire to shift the burden of proof onto industry, it is clear that EPA will have much more work to do with the updated regulations. In short, much more information means much more review. In the EU, REACH created an entirely new agency to do the work. In the US, EPA has struggled with reduced funding for many years, and the current economic situation most assuredly will limit any new funding to deal with new mandates.

So what will the final Safe Chemicals Act look like? We don't know for sure. But it's a safe bet that after the November elections it will shift from the more environmental/health friendly tone of the current bills to a more industry friendly tone in the final bills likely to be reintroduced in 2011.

Climate Scientists James Hansen and Robert Watson Win Prestigious Blue Planet Prize

Climate scientists have recently been fending off harassment, professional character assassination, and even death threats as lobbying groups have stepped up their attacks on the science. But this past week two prominent climate scientists were named as recipients of the 2010 Blue Planet Prize, which is "an international environmental award...considered to be Japan's equivalent of the Nobel Prize."

The two winners are Dr. James Hansen, director at NASA's Goddard Institute for Space Studies and adjunct professor in the Department of Earth and Environmental Sciences at Columbia University. Hansen is well known in the United States for his vocal communication of the urgency of climate change. The other winner is British scientist Dr. Robert Watson, who is chief scientific adviser of the UK Department for Environment and chair of environmental science and science director at Tyndall Centre for Climate Change Research, the University of East Anglia. Watson is the former head of the IPCC.

According to the attached announcement:

"the prize, first awarded in 1992, is sponsored by the Asahi Glass Foundation. It goes to individuals or organizations with outstanding achievements in applied scientific research who have helped to solve global environmental problems.Watson and Hansen will receive their awards on October 26 in Tokyo, where they will each give a commemorative lecture."

In 1992, the year of the United Nations Earth Summit in Rio de Janeiro, the Asahi Glass Foundation established the Blue Planet Prize, "in the hopes of encouraging efforts to bring about the healing of the Earth's fragile environment."

China Publishes Revised Draft Guidance for Chemicals Notification

While REACH dominates the attention of Europe and TSCA reform is keeping everyone in the US guessing, the Chinese Environment Ministry has updated its draft guidance to reflect changes to the Environmental Management on New Chemical Substances law. Comments on the draft guidance are open until 1 July. In short, it is China REACH.

Entry in force of the law is set for October 2010 and several big changes are included. For example, new chemicals to be notified much be classified according to the UN Globally Harmonized System (GHS). The new law also introduces a new category of highly toxic, persistent and bioaccumulative substances (PBTs), and a new system of volume-based notification. There also is some reduced requirements for low-risk substances.

In anticipation of the new law, the Environment Ministry has published six guidance documents covering the requirements of the new law, though at this point they are only in Chinese. But a stakeholder's workshop will be held in Beijing on June 25, 2010 for those able to make it.

ECHA Adds Eight New Substances of Very High Concern to the REACH Candidate List

The European Chemicals Agency (ECHA) recently added eight additional chemical substances to the candidate list of Substances of Very High Concern (SVHC). Once on the candidate list the substances are eligible for entry onto Annex XIV and the authorization phase of REACH. Authorization means that companies would have to first apply to be "authorized" for continued use, but that use could be very much restricted and only for a limited period of time while substitutes are being developed.

The eight substances and the criteria for listing are:

Anhydrous disodium tetraborate - Reproductive toxicity

Boric acid - Reproductive toxicity

Ammonium dichromate - Carcinogenicity, Mutagenicity, and Reproductive toxicity

Potassium chromate - Carcinogenicity, Mutagenicity

Potassium dichromate - Carcinogenicity, Mutagenicity, and Reproductive toxicity

Sodium chromate - Carcinogenicity, Mutagenicity, and Reproductive toxicity

Tetraboron disodium heptaoxide hydrate - Reproductive toxicity

Trichloroethylene - Carcinogenicity

The addition of these SVHCs brings the total number of substances to date on the candidate list to 38, with the intent to increase the number listed to 135 by 2012.

More information on the candidate list can be found on the ECHA website.

Soap and Detergent Association Renames Itself the American Cleaning Institute

It's official. The American Cleaning Institute(ACI) is the new name of the former Soap and Detergent Association (SDA). While SDA had announced the change several months ago it has now official and the new website (www.CleaningInstitute.org) has gone live.

From ACI's press release:

"Our new name, brand and website enable us to better tell the story of how cleaning products and practices contribute to better living," said ACI Board Chair Jane Hutterly, EVP of Worldwide Corporate & Environmental Affairs, S.C. Johnson & Son, Inc. "Our industry's commitment to a more sustainable world and enhancing health and the quality of life is stronger than ever and will be well represented by the American Cleaning Institute."

Membership includes the manufacturers and formulators of household, industrial, and institutional cleaning products, their ingredients and finished packaging; oleochemical producers; and chemical distributors to the cleaning product industry. ACI and its members are dedicated to improving health and the quality of life through sustainable cleaning products and practices.

Two Symposia Examine Chemical Toxicity Testing in the US and Beyond

Two upcoming symposia will examine the development of new toxicity testing strategies in the midst of stakeholder negotiations with Congress over the recently introduced Safe Chemicals Act legislation. The meetings follow on to the 2007 National Research Council (NRC) report, "Toxicity Testing in the 21st Century: A Vision and a Strategy." The "NRC vision calls for a revolution in the science of testing chemicals for toxicity that will draw on major advances in scientific tools that are now available—or are rapidly evolving."

Three years later, how are we implementing these proposed changes, from a legal and policy perspective? What are the obstacles? What remains to be done? These two symposia will offer some answers. Both will be held in Washington DC but in two locations.

The Future of Chemical Toxicity Testing in the US: Creating a Roadmap to Implement the NRC's Vision and Strategy (Monday, June 21, 2010, 8am - 5pm, National Press Club)

The symposium will feature a keynote presentation by USEPA Assistant Administrator Stephen A. Owens and will convene a range of legal, policy, and scientific experts to discuss—

* The status of implementation of the vision for chemical toxicity testing three years after the NRC report was issued.
* What the federal agencies are doing—and planning to do—to ensure implementation of the NRC vision.
* Stakeholder perspectives on implementation across a range of viewpoints: industry, public health and environmental protection, the academy, and animal welfare.
* Where implementation of the NRC vision fits into a landscape of potentially broad legislative reform for toxic substances, harmonization with Canadian requirements, and scarcity of financial resources.

International Harmonization in Chemical Toxicity Testing: An EU Perspective on the Way Forward (Tuesday, June 22, 2010, 8am - 1:15pm, Johns Hopkins University School for Advanced International Studies)

EU regulations such as REACH and the 7th Amendment to the Cosmetics Directive have highlighted the crucial role of EU-US relations in the field of humane science. This symposium is intended to examine humane science and toxicity testing from the point of view of important EU stakeholders and experts. This half-day program features speakers from the European Commission, as well as policy leaders from major European corporations, member countries and academic institutions.

More information on both symposia, including agendas and speaker information, can be found at the symposia web site.

EU Commission Gets Close to Issuing Final PBT Chemical Annex for REACH

After much internal (and external) disagreement, the European Commission is finally ready to move ahead with its criteria for identifying Persistent, Bioaccumulative and Toxic chemicals (PBT), as well as those that are not toxic but are Very Persistent and Very Bioaccumulative (vPvB). This new version of what is called Annex XIII of REACH is being forwarded to the CARACAL group this week and could be published some time this fall.

CARACAL is an acronym for the Competent Authorities to REACH and Classification and Labelling (CARACAL). If the proposal is adopted a notification would be sent to the WTO for comment within 60 days, and if no hangups occur there it will enter the REACH comitology procedure. Assuming all goes well there then it will get published in the EU Official Journal and enter into force.

But this still isn't a done deal. The proposal, which relies on established PBT criteria and allows weight of evidence to be included, has been quite vigorously debated inside the Commission. Most of the disagreement has been over the use of weight of evidence (WoE). WoE was omitted from the original proposal in 2008 but now it seems it has been allowed in order to provide some flexibility in assessing the PBT or vPvB status of a chemical.

The PBT guidance is available on the ECHA web site.

So how is TSCA related to the BP Deepwater Horizon oil leak?

Apparently the NGO coalition called Safer Chemicals, Healthy Families is planning to continue its very high profile, very high activity advocacy for TSCA reform. Last week they held a webinar on TSCA reform and yesterday they did a conference call with the press to "announce a proposal and to help reporters make the connection between Corexit, the worrisome chemical dispersant being used to clean up the Gulf oil spill, and our nation’s failing system for regulating such chemicals, the Toxic Substances Control act of 1976 (TSCA)."

SCHF claims that "[w]hat’s going on in the Gulf is not an isolated incident — it’s a very dramatic, very public example of our nation’s broken system for managing chemicals." They go on to say

In their attempt to reassure Americans that Corexit was no more dangerous than common household products, chemical manufacturer Nalco unwittingly highlighted the fact that, because our laws are so weak, it’s entirely possible that our household products are quite dangerous! The reality is, our laws don’t require companies to show household products are safe before they arrive under our kitchen sinks, any more than they have to prove chemical dispersants are safe before they get dumped into our oceans. Hardly reassuring.

The group released a comparison chart showing the provisions of TSCA as it currently stands and how the Senate and House bills could "fix the problem." They go further and recommend what they believe are necessary additions to the current Safe Chemical Act proposals that would have required dispersants to demonstrate safety BEFORE being used in emergency situations like the Deepwater Horizon disaster (indicated in red in the chart).

Needs of Downstream Users Critical to Safe Chemicals Act Developments

"The impact of chemicals on business is felt well beyond the factories where chemicals are manufactured or processed into other substances and mixtures," said Bob Sussman at last week's Business and NGO Forum on Safer Chemicals Policy Reform. Sussman, who is a senior policy counsel to EPA Administrator Lisa Jackson, went further and noted that "companies at the end of the value chain" have a unique position because they serve "a critical interface where the public comes into contact with chemical-containing products." As such, these downstream users (DUs) must play an active role in helping to define the developing Safe Chemicals Act (or Toxic Substances Safety Act in the House).

The forum was designed to do just that. Sponsors included the NGO Safer Chemicals, Healthy Families coalition, the Business-NGO Working Group, and the American Sustainable Business Council. Points of discussion included a widespread agreement on the need for transparency, harmonization with other chemicals programs, and an emphasis on encouraging development of safer alternatives. Unlike some of the chemical trade associations, members of the Business-NGO Working Group strongly support a minimum data set on chemicals to be generated within five years. In short, they want to see data on all chemicals, not just a select few, so that there is enough information on potential alternatives to make sure they aren't just as bad as the ones that are being replaced. That can't be done unless there are data on everything.

According to Safer Chemicals, Healthy Families, there is an expectation that votes on the House's Toxic Substances Safety Act could begin some time this month. Some even suggest that a floor vote could happen before the summer is up. Still, it seems rather unlikely that any bill will be passed by both the House and Senate this year given the paucity of actual legislation days left and the critical (and often contentious) mid-term elections on every legislators mind.

Petrochemical Manufacturers and Refiners Comment on TSCA Chemical Reform Bills

Specialty chemical manufacturer and downstream user positions on the proposed TSCA reform bills introduced on April 15th were discussed in previous posts. Today the National Petrochemical & Refiners Association weighs in on the topic. NPRA represents virtually all US refiners and petrochemical manufacturers, whose members "supply consumers with a wide variety of products and services that are used daily in homes and businesses."

Like others, NPRA is concerned that the House discussion draft "significantly broadens the scope of TSCA by substantially changing the definition of 'substance' and 'mixture' to include practically any manufactured or processed good." And that makes the proposed law totally unworkable in a practical sense. NPRA is also concerned that most actions could actually be taken by EPA without the current provisions of "public notice and comment," which they say results in a lack of transparency. The draft also eliminates most opportunities for judicial review, thus potentially allowing arbitrary and unchallengeable decisions by EPA.

NPRA also feels that while there has been much emphasis on green chemistry and innovation, the "draft legislation imposes barriers to innovation that will inhibit all chemistry, including green chemistry policy and goals." They offer as an example the minimum data set requirement, which they feel will "raise the barrier of entry into the marketplace for new products as there will be a large cost imposed on companies to conduct the required testing and gather the required information for a single product." They claim that there is "an inversely proportional relationship between barriers of entry and the number of products introduced into any given market." They note that the minimum data set requirement in Europe has allowed the introduction of only 4000 new chemicals while the US introduced 18,000 in the same period.

As with the other trade associations, NPRA talks about the issues they see with prioritization, imminent hazard provisions, lack of preemption of state regulations, fees, what they see as unnecessary the emphasis on giving PBT chemicals special attention.

I'll look closer at key issues that pop up in most of the comments in future posts.

EU Takes Steps to Reduce Animal Experimentation

Two new steps have been taken in Europe to reduce the number of animals used in scientific testing.

In the first, the Council of the European Commission adopted what is called its "first-reading position" on a draft directive for the protection of animals used for scientific purposes. Under the provisions of the directive, member states would be required to pass legislation that ensures (among other things):

- experiments with animals are replaced, wherever possible, by an alternative method that is scientifically satisfactory,

- the number of animals used in projects is reduced to a minimum without compromising the quality of the results, and

- the degree of pain and suffering caused to animals is limited to the minimum.

In a second move, the European Chemicals Agency (ECHA) issued a "practical guide" on how to avoid unnecessary testing on animals in support of REACH registrations. ECHA anticipates that there will be between 25,000 and 75,000 registrations before the November 30, 2010 deadline. The vast majority of these will not require additional animal testing, and in fact, any animal testing specified in Annexes IX and X of REACH are required to be proposed for ECHA review only at this time. In addition, many companies are working together in consortia to create data packages that all companies can share, thus reducing all kinds of testing. The practical guide gives specific steps that companies can take to fill data gaps with non-animal data, for example QSARs, read-across, in vitro studies, the use of categories, and weight-of-evidence when literature data are available.

Lessons learned under the REACH program will likely be transferred to the new US chemical control law currently under development.

Downstream User Groups Comment on Upcoming House TSCA Chemical Reform Bill

As the House readies its formal introduction of their version of the TSCA reform bill, called the Toxic Substances Safety Act, various stakeholders are offering their views on what it should include. Or more accurately perhaps, what it shouldn't include. Friday I talked about what SOCMA thinks in representing their mostly smaller specialty chemical manufacturers. Today are downstream user organizations such as the Consumer Specialty Products Association (CSPA), the Grocery Manufacturers Association (GMA), and the Soap and Detergent Association (SDA, soon to become the American Cleaning Institute).

Like other industry trade associations, these downstream user (DU) groups see the need for TSCA modernization. But they are also concerned about the burden this may put on DUs. One of their primary concerns with the discussion draft seems to be the language that would expand TSCA to cover all chemical substances, mixtures, and articles (things made from substances and mixtures). As written, they say, "every single change to a mixture and article would constitute a 'new use' and require notification and approval by EPA." Given that consumer product manufacturers routinely "substitute new ingredients, use alternate material suppliers, switch among color shades and scents, and tweak formulations to rebalance existing ingredients in different proportions," such language could become a nightmare for downstream users. Which is one of the reasons that I think the mixture and article provisions will likely be dropped from the final bill and dealt with separately.

The DUs have many other concerns as well, and some of which overlap the major and specialty manufacturers' complaints like, e.g., questions about the minimum data set, priority setting, safety standards, CBI, etc. I'll look at each of these in more depth in future posts.